The Study On Technology And Quality Evaluation Of Four Herbs Sustained-release Pellet

Objective:(1)The new method which was found by my mentor for the pharmacokinetic study on TCM statistical moment of total quantum, was proved and developed by the study on Four Herbs decoction (2)Four Herbs decoction has nourishing and regulateing blood effects and used for syndrome of blood deficiency completed by blood stasis. A systematic study on its pharmacokinetics, preparation, quality standards had been made to insure its effects and quality by the author, and could be refered when other TCM was studied.Methods:(1) The pharmacokinetic study on the Four Herbs decoction was carried by statistical moment of total quantum; (2)With the amount of extraction, the contents of Catalpol, Ferulic acid, Paeoniflorin in the liquid of extraction as indexes, the extraction and drying process was selected by overall desirability method according to the central composite design. (3) To screen better excipient and better ratio of the excipients and to improve the formability of the pellet, formulation process was optimized. (4) Some materials for covering pellet were investigated. To compare the dissolution rates of two kinds of processes in vitro, the similar degree and content of ferulic acid were determined by HPLC in the dissolution as index.(5)Herbs were identified by TLC. The content of standards were determined by HPLC. The HPLC fingerprint of the Four Herbs sustained-release pellet was also established.Results:The reasons for changing Four Herbs decoction into sustained-release pellet were provided by the pharmacokinetic study on the Four Herbs decoction; the extraction and drying process was optimized; The best excipients and its formula were seven extract and three MMC. The 5%PVPk30 was used as binder. The coating material, Eudragit RS 100:Eudragit RL(1:5.2) with coating weight of 11.6%,The dissolved amount of sustained-release pellet was more than 90% at 24hour. The method of quality control is simple, accurate, reproducible. There is correlation between the vitro releasing degree and vivo pharmacokinetic parameters of sustained-release pellet.Conclusions:The new method for the pharmacokinetic study on TCM ,statistical moment of total quantum, was proved and developed .The preparation process is stable and feasible, and the quality standard is specific and reproducible. The study of stability is also investigated. Then it can make the best use of the clinical results.